Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-angle Glaucoma (POAG) (SL)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT00913029
First received: June 1, 2009
Last updated: March 28, 2013
Last verified: March 2013
  Purpose

Prospective, unmasked, randomized evaluation of the iStent in patients with primary open-angle glaucoma. Patients will be randomized to one of two groups: 1) iStent, or 2) medication.


Condition Intervention Phase
Eye Diseases
Glaucoma, Open-Angle
Glaucoma
Device: iStent
Drug: latanoprost/timolol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Unmasked, Randomized Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-Angle Glaucoma

Resource links provided by NLM:


Further study details as provided by Glaukos Corporation:

Primary Outcome Measures:
  • Mean intraocular pressure (IOP) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: May 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Stent
One hundred patients will be randomized to implantation of two G2 stents in at least one eye.
Device: iStent
iStent
Other Name: stent, Trabecular micro bypass
Active Comparator: Medication
One hundred patients will be randomized to receive a fixed combination ocular hypotensive medication.
Drug: latanoprost/timolol
Combination latanoprost/timolol

Detailed Description:

Two hundred patients will be enrolled in the study at up to 21 clinical sites; follow-up is through 1 year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of primary open-angle glaucoma
  • Male or female at least 18 years of age and able to provide written informed consent
  • Mean IOP (at baseline visit after washout of any medications) must be 22 mm Hg and no greater than 38 mm Hg
  • Likely to be available and willing to attend follow-up visits

Exclusion Criteria:

  • Angle closure glaucoma
  • Secondary glaucomas
  • Prior glaucoma procedures
  • Elevated episcleral venous pressure from history of active thyroid orbitopathy, carotid-cavernous fistula, orbital tumors, or orbital congestive disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00913029

Locations
Austria
Allgemeines Krankenhaus Wien
Wien, Austria, 1090
France
CHU de Lyon Hopital Edouard Herriot
Lyon, France, 69437
CHNO des Quinze-Vingts
Paris, France, 75012
Germany
Knapschaftskrankenhaus Bochum Langendreer
Bochum, Germany, 44892
Helios Cliniic
Erfurt, Germany, 99089
Universitatsklinkum Erlangen
Erlangen, Germany
Greece
AHEPA Hospital
Thessaloniki, Greece, 546 36
Italy
Universita'degli Studi di Parma
Parma, Italy, 43100
Universita' di Torino/Dipartimento di Fisiopatologia Clinica-Clinica Oculistica
Torino, Italy, 10128
Azienda Ospedaliera S. Maria della Misericordia
Udine, Italy, 33100
Poland
Military Health Service Institute
Warsaw, Poland, 00-909
Spain
Hospital Torrevieja Salud, UTE
Alicante, Spain, 03186
Hospital Clinico San Carlos
Madrid, Spain, 28040
Sponsors and Collaborators
Glaukos Corporation
Investigators
Study Director: Jeff Wells, PharmD, MBA Glaukos Corporation
  More Information

No publications provided

Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT00913029     History of Changes
Other Study ID Numbers: Second Line, Second Line Trial
Study First Received: June 1, 2009
Last Updated: March 28, 2013
Health Authority: Italy: Ethics Committee
Poland: Ministry of Health
Greece: Ethics Committee
Austria: Ethikkommission
Germany: Ethics Commission
Spain: Ethics Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Glaukos Corporation:
primary open angle glaucoma (POAG)
OAG
glaucoma

Additional relevant MeSH terms:
Eye Diseases
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Latanoprost
Antihypertensive Agents
Timolol
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on August 28, 2014